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Coronavirus InfectionPhase 2STOICNCT04416399

STerOids in COVID-19 Study

A Phase 2 study testing Budesonide dry powder inhaler in people with Coronavirus Infection, run by University of Oxford at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

At the time of writing (3/4/2020), close to a million people have been infected by the SARS-CoV-2 coronavirus around the world. The severe clinical condition that leads to deaths is now called CoVID-19. Currently, there are no effective treatments for the early or late stages of this illness. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus Infection
What is being tested?
Budesonide dry powder inhaler
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteUnited Kingdom
Study dates
16 Jul 2020to 12 Jan 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant is willing and able to give informed consent for participation in the trial
  • Male or Female, aged 18 years or above
  • New onset of symptoms suggestive of COVID-19 e.g. new onset cough and/or fever, and/or loss of smell or taste within 7 or fewer days of participant being seen at visit 1
  • In the Investigator's opinion, is able and willing to comply with all trial requirements

Who cannot join

  • A known allergy to investigational medicine product (IMP) (budesonide)
  • Any known contraindication to any of the IMPs (budesonide)
  • Patient currently prescribed inhaled or systemic corticosteroids
  • Recent use, within the previous 7 days of inhaled or systemic corticosteroids
  • Patient needs hospitalisation at time of study consent
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
  • Participants who have participated in another research trial involving an investigational product in the past 12 weeks.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Oxford Respiratory Trials Unit

    Oxford, Oxfordshire, OX3 7LE

Other trials in United Kingdom

About this study

Official title: Use of High Dose Inhaled Corticosteroids as Treatment of Early COVID-19 Infection to Prevent Clinical Deterioration and Hospitalisation

At the time of writing (3/4/2020), close to a million people have been infected by the SARS-CoV-2 coronavirus around the world. The severe clinical condition that leads to deaths is now called CoVID-19. Currently, there are no effective treatments for the early or late stages of this illness. Governments worldwide have undertaken dramatic interventions to try and reduce the rate of spread of this deadly coronavirus.

Early data from multiple studies in China, where the virus originated, show that severe cases of CoVID-19 are not as prevalent in patients with chronic lung diseases as expected. This data has been confirmed by the Italian physicians. The investigators think that the widespread use of inhaled corticosteroids reduces the risk of CoVID-19 pneumonia in patients with chronic lung disease. Early microbiological data also shows that these corticosteroids are effective at slowing down the rate of coronavirus replication on lung cells.

Read more

Inhaled corticosteroids are widely used to manage common lung conditions, such as asthma. This type of medicine is among the top 3 most common medication prescribed around the world. Their safety is well understood, and their potential side effects are mild and reversible.

The investigators propose to test this idea that, in participants early in the course of CoVID-19 illness, daily high dose inhaled corticosteroids for 28 days, will reduce the chances of severe respiratory illness needing hospitalisation. We will also study the effect of this inhaled therapy on symptoms and viral load.

Being tested
Budesonide dry powder inhaler
Keywords
CoVID-19, Coronavirus infection, SARS-CoV-2
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Budesonide dry powder inhalerDrug

    Also called Pulmicort

    Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day

Study groups in NCT04416399
Study groupRoleWhat they receive
Inhaled budesonideExperimentalBudesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day
Receives: Drug: Budesonide dry powder inhaler
Standard of careNo interventionStandard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Emergency department attendance of hospitalisation related to COVID-19

    Evaluate the effect of intervention on emergency department attendance or hospitalisation related to COVID-19

    Measured: Day 1 to day 28

Secondary outcomes (5)

  1. Body temperature

    Evaluate the effect of intervention on body temperature

    Measured: Day 1 to day 14

  2. Blood oxygen saturation level

    Evaluate the effect of intervention on blood oxygen level

    Measured: Day 1 to day 14

  3. Symptoms as assessed by common cold questionnaire

    Evaluate the effect of intervention on patient's symptoms as determined by common cold questionnaire. Higher score meaning worse symptoms.

    Measured: Day 1 to day 14

  4. Symptoms as assessed by FluPro questionnaire

    Evaluate the effect of intervention on patient's symptoms as determined by FluPro questionnaire. Higher score meaning worse symptoms.

    Measured: Day 1 to day 14

  5. Nasal/throat swab SARS-CoV-2 viral load

    Evaluate the effect of intervention on nasal and throat swab SARS-CoV-2 viral load

    Measured: Day 1, 7 and 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start16 Jul 2020
  3. Primary completion12 Jan 2021
  4. Study completion12 Jan 2021

Why it stopped: Independent statistical review advice

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised, open label parallel group controlled clinical trial
Masking
None (open label)
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04416399
Sponsor's protocol ID
STOIC study
Acronym
STOIC
Status last verified
Jul 2020
First submitted
3 Jun 2020
Last updated
8 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cass SP, Nicolau DV Jr, Baker JR, Mwasuku C, Ramakrishnan S, Mahdi M, Barnes PJ, Donnelly LE, Martinez-Nunez RT, Russell REK, Bafadhel M. Coordinated nasal mucosa-mediated immunity accelerates recovery from COVID-19. ERJ Open Res. 2024 May 13;10(3):00919-2023. doi: 10.1183/23120541.00919-2023. eCollection 2024 May.

    PubMed 38746861

  • Baker JR, Mahdi M, Nicolau DV Jr, Ramakrishnan S, Barnes PJ, Simpson JL, Cass SP, Russell REK, Donnelly LE, Bafadhel M. Early Th2 inflammation in the upper respiratory mucosa as a predictor of severe COVID-19 and modulation by early treatment with inhaled corticosteroids: a mechanistic analysis. Lancet Respir Med. 2022 Jun;10(6):545-556. doi: 10.1016/S2213-2600(22)00002-9. Epub 2022 Apr 7.

    PubMed 35397798

  • Ramakrishnan S, Nicolau DV Jr, Langford B, Mahdi M, Jeffers H, Mwasuku C, Krassowska K, Fox R, Binnian I, Glover V, Bright S, Butler C, Cane JL, Halner A, Matthews PC, Donnelly LE, Simpson JL, Baker JR, Fadai NT, Peterson S, Bengtsson T, Barnes PJ, Russell REK, Bafadhel M. Inhaled budesonide in the treatment of early COVID-19 (STOIC): a phase 2, open-label, randomised controlled trial. Lancet Respir Med. 2021 Jul;9(7):763-772. doi: 10.1016/S2213-2600(21)00160-0. Epub 2021 Apr 9.

    PubMed 33844996

  • Farne H, Singanayagam A. Reply. J Allergy Clin Immunol. 2021 Mar;147(3):1117-1118. doi: 10.1016/j.jaci.2020.11.019. Epub 2020 Dec 30. No abstract available.

    PubMed 33388170

  • Nicolau DV, Bafadhel M. Inhaled corticosteroids in virus pandemics: a treatment for COVID-19? Lancet Respir Med. 2020 Sep;8(9):846-847. doi: 10.1016/S2213-2600(20)30314-3. Epub 2020 Jul 30. No abstract available.

    PubMed 32738928

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Budesonide dry powder inhaler in people with Coronavirus Infection, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Independent statistical review advice). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emergency department attendance of hospitalisation related to COVID-19 (time frame: Day 1 to day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04416399, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.

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